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FDA 510(k)

Disposable Injection Needles

K-Number: K232200 · 2024-04-12

ApplicantNingbo Xinwell Medical Technology Co., Ltd.
Decision Date2024-04-12
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Injection Needles is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Xinwell Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K232200. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Injection Needles?

Disposable Injection Needles is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Ningbo Xinwell Medical Technology Co., Ltd.. The 510(k) number is K232200.

When did Disposable Injection Needles receive FDA 510(k) clearance?

Disposable Injection Needles received FDA 510(k) clearance on 2024-04-12, under 510(k) number K232200.

Who is the listed applicant for Disposable Injection Needles?

The FDA 510(k) record lists Ningbo Xinwell Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Injection Needles?

The FDA product code for Disposable Injection Needles is FBK.

Other records listing Ningbo Xinwell Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232969Disposable Hemostatic Clips

Related Devices (Code: FBK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems CorporationK241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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